NCT00529932.

Trial name or title	A trial using CD133 enriched bone marrow cells following primary angioplasty for acute myocardial infarction (SELECT‐AMI)
Methods	Type of study: parallel RCT Source of funding: not reported Country of origin: Belgium, France, The Netherlands, United Kingdom Number of centres: 4 Intended enrolment: 19
Participants	Population: AMI Age, mean (SD) each arm: not reported (20 to 75 years) Sex, % male in each arm: not reported Number of diseased vessels: not reported Number of stunned hyperkinetic, etc segments: presence of severe hypokinesia and/or akinesia in >= 2 adjacent segments on echocardiogram at 48 to 72 hours after primary PCI Time from symptom onset to initial treatment: 2 to 24 hours after onset of chest pain Statistically significant baseline imbalances between the groups?: not reported
Interventions	Intervention arm: CD133+ cells Type of stem cells: bone marrow‐derived selected CD133+ cells Summary of how stem cells were isolated and type and route of delivery: bone marrow aspirated, CD133+ cells selected, intracoronary injection of autologous CD133+ cells Dose of stem cells: not reported Timing of stem cell procedure: not reported Comparator arm: buffered normal saline
Outcomes	Primary outcomes: 1) Safety ‐ progression in coronary atherosclerosis burden proximal and distal to the stented segment of the infarct‐related artery, 2) Efficacy ‐ changes in myocardial thickening in non‐viable akinetic/hypokinetic LV wall segments by cardiac magnetic resonance imaging (cMRI) Secondary outcomes: 1) Safety ‐ development of ventricular arrhythmias including failed sudden cardiac death, development of congestive heart failure 2) Efficacy ‐ LVEF, epicardial resistance and microvascular resistance, the feasibility of the CliniMACS® Reagent System to yield 5 x 106 CD133+ cells from 100 to 150 mL of autologous bone marrow Outcome assessment points: baseline and 6 months Method(s): cMRI, echocardiography
Starting date	September 2007
Contact information	Jozef Bartunek, MD (jozef.bartunek@olvz‐aalst.be); Jonathan Hill, MD (jonathan.hill@kcl.ac.uk)
Notes	This study has been terminated due to insufficient recruitment